Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
they use HD for 60 plus (Fluzone High-Dose) with no reported adverse event; Initial information received on 11-May-2026 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a male patient reporter reported use HD for 60 plus (trivalent influenza vaccine (Fluzone High-Dose)) with no reported adverse event The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unspecified date, the patient received trivalent influenza vaccine suspension for injection (strength: unknown) at an unknown dose and frequency via an unknown route for prophylactic vaccination (immunization) The reporter stated that they used the high-dose formulation for patients aged 60 years and above (Fluzone High-Dose) with no reported adverse event (product administered to patient of inappropriate age, onset date: unknown and latency:same day) (batch: unknown, expiry date: unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. They were actually using for 65plus and not 60 plus Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medication error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Comments: NONE